Hyperactivity, concentration difficulties and impulsiveness improve during seven weeks' treatment with valerian root and lemon balm extracts in primary school children.
Study Design
- 研究类型
- Observational Study
- 样本量
- 169
- 持续时间
- 7 weeks
- 干预措施
- Hyperactivity, concentration difficulties and impulsiveness improve during seven weeks' treatment with valerian root and lemon balm extracts in primary school children. 640 mg valerian root extract WS 1014 + 320 mg lemon balm extract WS 1303 (Sandrin) daily
- 对照组
- Placebo
- 效应方向
- Positive
- 偏倚风险
- High
Abstract
BACKGROUND: Valerian root and lemon balm extracts have previously shown efficacy and excellent tolerability in children<12 years suffering from restlessness and insomnia. We now examined whether treatment with a fixed combination of both may also improve concentration, hyperactivity and impulsiveness. METHODS: 169 primary school children suffering from hyperactivity and concentration difficulties but not meeting ADHS criteria were treated in an observational study by 27 office based pediatricians with a recommended daily dose of 640 mg valerian root extract WS(®) 1014 and 320 mg lemon balm extract WS(®) 1303 (Sandrin(®)), and evaluated by pediatricians and parents using standardized questionnaires at baseline, weeks 2 and 7. RESULTS: The fraction of children having strong/very strong symptoms of poor ability to focus decreased from 75% to 14%, hyperactivity from 61% to 13%, and impulsiveness from 59% to 22%. Parent rated social behavior, sleep and symptom burden showed highly significant improvements. Only in two children mild transient adverse drug reactions were observed. CONCLUSION: In primary school children with restlessness, concentration difficulties and impulsiveness treatment with WS(®) 1014 and WS(®) 1303 (Sandrin(®)) provides a viable option in addition to counseling and education.
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